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El ensayo clínico NCT04888988 (CIPN) para Neuropatía periférica inducida por quimioterapia, Neoplasia de células hematopoyéticas y linfoides, Neoplasia Sólida Maligna está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Universidad de RochesterTesting the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT04888988 (CIPN) es un ensayo intervencionista para Neuropatía periférica inducida por quimioterapia, Neoplasia de células hematopoyéticas y linfoides, Neoplasia Sólida Maligna. Su estado actual es: activo, no reclutando. El ensayo se inició el 25 de febrero de 2022, con el objetivo de reclutar a 133 participantes. Dirigido por la Universidad de Rochester, se espera que finalice el 1 de febrero de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 21 de noviembre de 2025.
Resumen
This phase II trial studies whether using exercise is better than the usual approach for treating chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy damages the nerves communicating between the brain, spinal cord, and the rest of the body. The usual approach for treating CIPN is treatment with drugs that help reduce symptoms of other types of neuropathy (for example, from diabetes). However, these drugs do not treat all symptoms of CIPN. Exercise may help to reduce CIPN symptoms.
Descripción detallada
PRIMARY OBJECTIVE:
I. Assess the preliminary efficacy of exercise versus (vs.) standard care for treating CIPN (via patient-reported CIPN-20 total score).
SECONDARY OBJECTIVES:
I. Assess the preliminary efficacy of exercise vs. standard care on individual symptoms of CIPN (via CIPN Symptom Inventory; i.e., numbness, tingling, burning/shooting pain, and cramping in the hands and feet).
II. Assess the preliminary efficacy of exercise vs. standard care on a clinical test of CIPN symptoms (via the tactile sensitivity in the fingers and toes).
III. Assess the effects of exercise vs. standard care on two possible CIPN mechanisms, namely interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 [MAIA-2] questionnaire).
EXPLORATORY OBJECTIVES:
I. Assess the effects of exercise vs. standard care on other common symptoms related to cancer, chemotherapy, and CIPN, including:
Ia. Daily Diary of symptoms of CIPN. Ib. An array of cancer and treatment symptoms (MD Anderson Symptom Inventory; MDASI).
Ic. Anxiety and depression (hospital anxiety and depression scale; HADS). Id. Pain catastrophizing (pain catastrophizing scale; PCS). Ie. Cognitive impairment (Functional Assessment of Cancer Therapy-Cognitive [FACT-Cog]).
If. Fatigue (brief fatigue inventory; BFI). Ig. Quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1 (EXERCISE): Participants undergo the exercise for cancer patients (EXCAP) intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5.
ARM 2 (CONTROL): Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes.
Participants may optionally undergo magnetic resonance imaging (MRI) on study.
Título oficial
Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Condiciones médicas
Neuropatía periférica inducida por quimioterapiaNeoplasia de células hematopoyéticas y linfoidesNeoplasia Sólida MalignaOtros ID del ensayo
- CIPN
- URCC19075
- R21CA256154 (Subvención/contrato NIH (EE. UU.))
- UG1CA189961 (Subvención/contrato NIH (EE. UU.))
- NCI-2020-11456 (Identificador de registro) (CTRP (Clinical Trial Reporting Program))
- URCC19075 (Otro identificador) (University of Rochester NCORP Research Base)
- URCC-19075 (Otro identificador) (DCP)
- URCC-19075 (Otro identificador) (CTEP)
Número del NCT
Inicio del ensayo (real)
2022-02-25
Última actualización
2025-11-21
Fecha de finalización (estimada)
2026-02-01
Inscripción (prevista)
133
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Objetivo principal
Cuidados de apoyo
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalArm 1 (EXCAP, tactile sensitivity test, counseling) Participants undergo the EXCAP intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5. Participants may optionally undergo MRI on study. | Asesoramiento en ejercicio Meet with certified exercise instructor Intervención de ejercicio Participate in the EXCAP program Imagen por resonancia magnética Undergo MRI Neuropathy Assessment Undergo tactile sensitivity test Administración de cuestionarios Ancillary studies |
Comparador activoArm 2 (usual care, tactile sensitivity test) Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. Participants may optionally undergo MRI on study. | Mejor práctica Receive standard of care Asesoramiento en ejercicio Meet with certified exercise instructor Intervención de ejercicio Participate in the EXCAP program Imagen por resonancia magnética Undergo MRI Neuropathy Assessment Undergo tactile sensitivity test Administración de cuestionarios Ancillary studies |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity | Will estimate the effects of exercise versus usual care on CIPN using analysis of covariance (ANCOVA). Will be measured by the mean European Organization for Research and Treatment of Cancer-CIPN20. The model will include CIPN-20 at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest and the pre-intervention CIPN-20 score as a covariate. | Week 6 post randomization |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Effects of exercise on the severity of CIPN symptoms | We will estimate the effects of exercise vs. usual care on CIPN symptoms (i.e., hot/burning or sharp/shooting pain in the hands or feet, numbness or tingling in the hands or feet) collected from the daily symptom inventory (0-10 severity) using analysis of covariance (ANCOVA). The model will include the average of daily symptom inventory for each CIPN symptom at post-intervention as the outcome, controlling for the average of daily symptom inventory for each CIPN symptom at pre-intervention. | Up to 6 weeks post randomization |
Effects of exercise on tactile sensitivity | We will estimate the effects of exercise vs. usual care on tactile sensitivity in the fingers and toes, assessed via an established touch test procedure with a set of monofilaments, using analysis of covariance (ANCOVA). The model will include the tactile sensitivity score at post-intervention as the outcome, controlling for the pre-intervention score. | Up to 6 weeks post randomization |
Effect of exercise on interoception | We will estimate the effects of exercise vs. usual care on interoception, measured via the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), using analysis of covariance (ANCOVA). The model will include the MAIA-2 total score at post-intervention as the outcome, controlling for the pre-intervention MAIA-2 total score. | Up to 6 weeks post randomization |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Have a diagnosis of cancer
- Have received neurotoxic chemotherapy within the past nine months (could still be on chemotherapy or have already completed chemotherapy; i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy
- Report one or more symptoms of CIPN at a level of >= 4 on the CIPN symptom inventory on the Screening Form
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Have at least six months life expectancy
- Be at least 18 years of age
- Be able to read and understand English
- Be able to provide written informed consent
- Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance exercise program, according to the participant's physician (e.g., oncologist, primary care) or physician's designee
- Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form
- Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed)
- Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant
- Are pregnant of have plans to become pregnant during the course of the study. Documentation of pregnancy and use of contraception can be obtained from the medical record.
- Have a current or prior cancer in the central nervous system (spine, brainstem, brain) as this would interfere with assessments of brain functional connectivity.
Universidad de Rochester193 ensayos clínicos activos para explorarInstituto Nacional del Corazón, los Pulmones y la Sangre, Estados Unidos3028 ensayos clínicos activos para explorarParte responsable del ensayo
Po-Ju Lin, Investigador principal, URCC Study Co-Chair, University of Rochester NCORP Research Base
No hay datos de contacto.
93 Sitios del ensayo en 1 países
California
Kaiser Permanente-Fresno, Fresno, California, 93720, United States
Contra Costa Regional Medical Center, Martinez, California, 94553-3156, United States
Kaiser Permanente-Roseville, Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons, Sacramento, California, 95814, United States
Kaiser Permanente-South Sacramento, Sacramento, California, 95823, United States
Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, 95119, United States
Kaiser Permanente San Leandro, San Leandro, California, 94577, United States
Kaiser San Rafael-Gallinas, San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051, United States
Kaiser Permanente-South San Francisco, South San Francisco, California, 94080, United States
Kaiser Permanente-Vallejo, Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek, Walnut Creek, California, 94596, United States
Colorado
Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital, Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, 80304, United States
Rocky Mountain Cancer Centers - Centennial, Centennial, Colorado, 80112, United States
The Women's Imaging Center, Denver, Colorado, 80209, United States
Colorado Blood Cancer Institute, Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose, Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers - Swedish, Englewood, Colorado, 80113, United States
The Melanoma and Skin Cancer Institute, Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, 80260, United States
Delaware
Beebe South Coastal Health Campus, Millville, Delaware, 19967, United States
Helen F Graham Cancer Center, Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States
Beebe Health Campus, Rehoboth Beach, Delaware, 19971, United States
District of Columbia
MedStar Georgetown University Hospital, Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center, Washington D.C., District of Columbia, 20010, United States
Hawaii
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States
Hawaii Cancer Care - Westridge, ‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center, ‘Aiea, Hawaii, 96701, United States
Illinois
SIH Cancer Institute, Carterville, Illinois, 62918, United States
Centralia Oncology Clinic, Centralia, Illinois, 62801, United States
Carle at The Riverfront, Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, 62526, United States
Decatur Memorial Hospital, Decatur, Illinois, 62526, United States
Crossroads Cancer Center, Effingham, Illinois, 62401, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, 62269, United States
Carle Cancer Center, Urbana, Illinois, 61801, United States
Iowa
Physicians' Clinic of Iowa PC, Cedar Rapids, Iowa, 52402, United States
Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, 52403, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States
Maryland
Christiana Care - Union Hospital, Elkton, Maryland, 21921, United States
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Brighton, Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton, Canton, Michigan, 48188, United States
Chelsea Hospital, Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, 48118, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, 49503, United States
University of Michigan Health - Sparrow Lansing, Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, 48154, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, 48197, United States
Minnesota
Mercy Hospital, Coon Rapids, Minnesota, 55433, United States
Unity Hospital, Fridley, Minnesota, 55432, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, 55416, United States
Regions Hospital, Saint Paul, Minnesota, 55101, United States
Ridgeview Medical Center, Waconia, Minnesota, 55387, United States
Rice Memorial Hospital, Willmar, Minnesota, 56201, United States
Missouri
Lake Regional Hospital, Osage Beach, Missouri, 65065, United States
Missouri Baptist Medical Center, St Louis, Missouri, 63131, United States
North Carolina
CaroMont Regional Medical Center, Gastonia, North Carolina, 28054, United States
CaroMont Health - Lincoln Cancer Center, Lincolnton, North Carolina, 28092, United States
FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States
Nash UNC HealthCare, Rocky Mount, North Carolina, 27804, United States
Ohio
Strecker Cancer Center-Belpre, Belpre, Ohio, 45714, United States
Fairfield Medical Center, Lancaster, Ohio, 43130, United States
Saint Rita's Medical Center, Lima, Ohio, 45801, United States
Marietta Memorial Hospital, Marietta, Ohio, 45750, United States
Licking Memorial Hospital, Newark, Ohio, 43055, United States
Southern Ohio Medical Center, Portsmouth, Ohio, 45662, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, 43701, United States
South Carolina
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, 29316, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, 29672, United States
Virginia
Chesapeake Regional Medical Center, Chesapeake, Virginia, 23320, United States
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay, Wisconsin, 54235-1495, United States